YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 302 drug applications between 27 June 2025 and 3 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 46 drug names.

2025/06/27 – 2025/07/03

Period
2025/06/27 to 2025/07/03, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
302
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
48

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

302filings, 67 of them generic

By application type

Application typeFilings
Supplement181
Generic67
New drug36
Import re-registration11
Import5
Unspecified2

By drug type

Drug typeFilings
Chemical drug171
TCM95
Therapeutic biologic35
Prophylactic biologic1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

46 drugs with new generic filings; top 10 listed

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

183 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized880
2Shanxi Hua Kang Pharma Co., Ltd. romanized770
3Pfizer Australia Pty Ltd720
4Guangxi Lai Bin Hu Lu Wa Pharma Co., Ltd. romanized660
5Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized650
6Lanzhou Tai Bao Pharmaceutical Co., Ltd. romanized640
7Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized630
8Topfond Pharmaceutical Co., Ltd.540
9Qilu Pharmaceutical Co., Ltd.530
10Celgene Corporation510

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

68 this week

AcceptedDrugApplicants
2025/07/03Generic · Class 3 Peramivir InjectionCYHS2502356 Shandong Yi Kang Pharma Co., Ltd. romanized
2025/07/03Generic · Class 3 注射用泮托拉唑钠(Ⅰ) · No verified English nameCYHS2502352 Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2025/07/03Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2502351 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/07/03Generic · Class 3 Multiple Vitamins InjectionCYHS2502350 Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/07/03Generic · Class 3 Atropine Sulfate InjectionCYHS2502347 Hubei Jin Yao Pharma Co., Ltd. romanized
2025/07/03Generic · Class 3 Cilostazol Orally Disintegrating TabletsCYHS2502346 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/07/03Generic · Class 3 Cilostazol Orally Disintegrating TabletsCYHS2502345 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/07/03Generic · Class 3 Cefazolin Sodium for InjectionCYHS2502344 Chi Feng Wan Ze Pharma Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2025/07/03Generic · Class 3 Cefazolin Sodium for InjectionCYHS2502343 Chi Feng Wan Ze Pharma Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2025/07/03Generic · Class 3 Cefazolin Sodium for InjectionCYHS2502342 Chi Feng Wan Ze Pharma Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2025/07/03New drug · Class 2.3 小儿肺热咳喘颗粒 · No verified English nameCXZL2500043 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2025/07/03New drug · Class 1 注射用SIM0609 · No verified English nameCXSL2500534 Shanghai Xian Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/07/03New drug · Class 1 SHR-3045注射液 · No verified English nameCXSL2500533 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/03New drug · Class 2.2 HECB2100401吸入喷雾剂 · No verified English nameCXHL2500636 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2025/07/03New drug · Class 1 CB03-154片 · No verified English nameCXHL2500635 Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized
2025/07/03New drug · Class 1 GFH276片 · No verified English nameCXHL2500634 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/07/03New drug · Class 1 GFH276片 · No verified English nameCXHL2500633 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/07/02Import · Class 1 AB248 (etakafusp alfa) 注射液 · No verified English nameJXSL2500116 Asher Biotherapeutics Inc.; PAREXEL CHINA CO. LTD
2025/07/02Import · Class 1 AZD2936 · No verified English nameJXSL2500115 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/02Generic · Class 3 Sodium Nitroprusside InjectionCYHS2502341 Sichuan Jian Lin Pharma Co., Ltd. romanized; Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2502338 Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2502334 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2502333 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502332 Guo Yue (Shandong) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502331 Guo Yue (Shandong) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/07/02New drug · Class 1 个性化树突状细胞注射液 · No verified English nameCXSL2500532 Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized
2025/07/02New drug · Class 1 个性化树突状细胞注射液 · No verified English nameCXSL2500531 Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized
2025/07/02New drug · Class 1 个性化树突状细胞注射液 · No verified English nameCXSL2500530 Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized
2025/07/02New drug · Class 1 BBT002注射液 · No verified English nameCXSL2500529 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/02New drug · Class 1 BBT002注射液 · No verified English nameCXSL2500528 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized

38 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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